FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128161–128184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1990
ASTRO-MED ASC-951 PRESSURE PROCESSOR
K894295 · DRQ
Astro-Med, Inc.
Cardiovascular · 209d
Cleared Jan 18, 1990
INAMED RHEMO-D (TM) DILATOR
K894618 · FFP
Inamed Development Co.
Gastroenterology & Urology · 182d
Cleared Jan 18, 1990
CARDIOPHONE
K894856 · DXH
Euro-American Marketing Group, Inc.
Cardiovascular · 171d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
DEFIB K-PADS
K895662 · LDD
Katecho, Inc.
Cardiovascular · 120d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · JJY
Bio-Rad
Toxicology · 104d
Cleared Jan 18, 1990
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
K896034 · DSB
D. E. Hokanson, Inc.
Cardiovascular · 94d
Cleared Jan 18, 1990
MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR
K896102 · DXN
Advanced Medical Products, Inc.
Cardiovascular · 87d
Cleared Jan 18, 1990
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR
K896103 · DSI
Advanced Medical Products, Inc.
Cardiovascular · 87d
Cleared Jan 18, 1990
IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
K896150 · IYO
Teknar, Inc.
Radiology · 87d
Cleared Jan 18, 1990
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · JPD
Bio-Rad
Hematology · 85d
Cleared Jan 18, 1990
KALOS 05 PULSE GENERATOR
K896184 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 85d
Cleared Jan 18, 1990
CYSTO PUMP DRAINAGE BAG
K896208 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
GASTRIC SUMP TUBE
K896210 · KNT
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
CYSTOSCOPY/IRRIGATION SET
K896211 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET
K896213 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
VIRAFREE CORP. EJECTABLE NEEDLE HOLDER
K896293 · FMI
Virafree Corp.
General Hospital · 79d
Cleared Jan 18, 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
K896346 · FPA
Pharmacia Deltec, Inc.
General Hospital · 76d
Cleared Jan 18, 1990
MIDA SYSTEM, MODELS 1000/1100
K896396 · DYC
Medical Graphics Corp.
Cardiovascular · 73d
Cleared Jan 18, 1990
MEDILOG OPTIMA
K896535 · DSK
Oxford Medilog, Inc.
Cardiovascular · 65d
Cleared Jan 18, 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.
K896569 · DRX
Jason Marketing Co.
Cardiovascular · 59d
Cleared Jan 18, 1990
CLINISTAT ALBUMIN REAGENT TEST
K896910 · CIX
Miles Diagnostics Div.
Chemistry · 38d
Cleared Jan 18, 1990
T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
K896925 · KHQ
In Vitro Diagnostics, Inc.
Chemistry · 37d